SHR-1210 Combined With Epirubicin in the Treatment of Extensive Disease Small Cell Lung Cancer

NCT03755115 | Unknown Phase 2 DMC

• 1 other identifier: SHR-1210-EPI-II
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with extensive disease SCLC after failure of first-line treatment were enrolled with SHR-1210 and epirubicin for 3 cycles to evaluate initial efficacy

Conditions

Small Cell Lung Cancer Extensive Stage

Keywords

ICD; PD1; ED-SCLC

Outcome Measures

Primary Outcomes (1)

• ORR

  Objective Response Rate

  6 month

Secondary Outcomes (5)

• PFS

  2 years

• DCR

  2 years

• OS

  2 years

• AE

  2 year

• characteristic antigen on the surface of immunogenic dead cells

  3 month

Study Arms (1)

Epirubicin plus SHR1210

EXPERIMENTAL

First intravenous injection of epirubicin injection, D1,30mg/m\^2 Then intravenous administration with SHR-1210,D1, a fixed dose of 200mg, D1,30min per infusion, Q2W. The total dose of epirubicin is 360 mg/m\^2.next SHR-1210 single drug maintenance .Until to secdonary disease progression or intolerance side effects.Evaluate efficacy every 3 cycles.

Drug: Epirubicin plus SHR1210

Interventions

Epirubicin plus SHR1210 DRUG

First intravenous injection of epirubicin injection, D1,30mg/m\^2 Then intravenous administration with SHR-1210,D1, a fixed dose of 200mg, 30min per infusion, Q2W. The total dose of epirubicin is 360 mg/m\^2.next SHR-1210 single drug maintenance .Until to secdonary disease progression or intolerance side effects.Evaluate efficacy every 3 cycles.

Epirubicin plus SHR1210

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is 18-75 years old when the informed consent form is signed, and the gender is not limited.
• Histological or cytological diagnosis of patients with extensive small cell lung cancer (ED-SCLC).
• Must provide specimens of tumor tissue at or after diagnosis of advanced or metastatic tumors or consent to biopsy, formalized or freshly obtained, formalin-fixed, paraffin-embedded (FFPE) within 1 month prior to the first dose. After the tumor tissue block can cut at least 10 slices for staining and detection.
• Subjects have undergone rapid progression or relapse of drug resistance after first-line treatment.
• According to the RECIST 1.1 standard, subjects must have a target lesion that can be measured by CT or MRI.
• , ECOG PS score: 0-1 points. 7. The expected survival period is ≥ 3 months. 8, the main organ function meets the following criteria: a) blood routine (no blood transfusion within 14 days, no G-CSF, no use of drugs to correct): absolute neutrophil ≥ 1.5 × 109 / L, platelets ≥ 100 × 109 / L, hemoglobin ≥ 90 g / L, white blood cells ≥ 4.0 × 109 / L and ≤ 15 × 109 / L; b) blood biochemistry: total bilirubin ≤ 1.5 ULN, AST / ALT ≤ 2.5 ULN, (if liver metastasis, then ≤ 5 times the upper limit of normal value), ALB ≥ 30 g / L, serum creatinine ≤ 1.5 ULN; c) Coagulation function: APTT ≤ 1.5 × ULN and prothrombin time - international normalized ratio (PT-INR) \< 1.5xULN ( Did not receive anticoagulant therapy).
• \. Volunteer to participate in clinical trials and sign informed consent, good compliance

You may not qualify if:

• History and comorbidities: 1) Exclude any active, known or suspected autoimmune disease in the subject 2) Exclude 2, use anti-tumor vaccine or other anti-tumor with immune stimulation within 1 month before the first dose Subjects treated with drugs. 3) Exclude subjects who are highly suspected of having interstitial pneumonia. 4) Subjects who excluded other active malignancies requiring simultaneous treatment excluded subjects with grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias, and grade III to IV cardiac insufficiency. 5) Exclude subjects with active tuberculosis (TB). 6) Exclude subjects who had severe infections within 4 weeks prior to the first dose. Exclude subjects with any active infection. 7) Exclude subjects who are ready or have undergone tissue/organ transplantation. 8) Exclude subjects who have been vaccinated or will be vaccinated within 30 days prior to the first dose.
• \. Physical examination and laboratory examinations 1) A known history of human immunodeficiency virus (HIV) is known or known to have acquired immunodeficiency syndrome (AIDS). 2) Untreated active hepatitis. 3) Exclude subjects with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage.
• , allergic reactions and adverse drug reactions 1) severe allergic reactions to other monoclonal antibodies. 2) Allergic or intolerant to the infusion. 3) Serious intolerance to epirubicin or toxicity.
• \. Exclude subjects with mental illness, alcoholism, refrain from quitting, drug use or substance abuse.

Sponsors & Collaborators

• Henan Cancer Hospital: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

Tian Tongde

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Interventions

Epirubicin; camrelizumab

Intervention Hierarchy (Ancestors)

Doxorubicin; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Tongde Tian

  Henan Cancer Hospital (The Affiliated Cancer Hospital of Zhengzhou University)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tongde Tian

CONTACT

0086-15093118217; tian_tong_de@163.com

Du Yang

CONTACT

0086-18737704121; 1061453586@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2018
• First Posted: November 27, 2018
• Study Start: February 1, 2019
• Primary Completion: October 28, 2019
• Study Completion: May 31, 2020
• Last Updated: January 16, 2019

Record last verified: 2018-11

Locations

CN (1)